MSCs For Treatment of Azoospermic Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02025270|
Recruitment Status : Recruiting
First Posted : January 1, 2014
Last Update Posted : June 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Male Infertility||Biological: Stem Cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2017|
Laboratory and Clinical
60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into rete testis.
Biological: Stem Cells
60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.
- All Cases Improvement [ Time Frame: One Year (12-Month) ]Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.
- All Cases Fertility Improvement [ Time Frame: One Year (12-Month) ]Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025270
|Contact: Taimour M Khalifa, MDemail@example.com|
|Contact: Sayed Bakry, PhDfirstname.lastname@example.org|
|Al Azhar University , School of Medicine||Recruiting|
|Nasr City, Cairo, Egypt, 11884|
|Contact: Sayed Bakry, PhD +201006609978 email@example.com|
|Principal Investigator: Taimour Khalifa, MD|
|Sub-Investigator: Sayed Bakry, PhD|
|Sub-Investigator: Hala Gabr, MD|
|Sub-Investigator: Wael Abu El Khier, MD|
|Principal Investigator:||Taimour M Khalifa, MD Professor||Al-Azhar University|
|Study Director:||Sayed Bakry, PhD||Al-Azhar University|
|Study Chair:||Hala Gabr, MD||Cairo University|
|Study Chair:||Wael Abu Elkhier, MD||Miltary Academy|
|Study Chair:||Saad Moneer, MSc||Al-Azhar University|
|Study Chair:||Yasser Aly Elsheikh, MD||Chairman of Urology & Andrology Department- Al Galaa Military Complex|
|Study Chair:||Ahmed Kadeh, MSc||Al-Azhar University|